Vivek K.
Validation Engineer | Lean Six Sigma Green Belt | CQV | Process Improvement | Pharmaceutical Process Improvement | Medical Device Manufacturing | DFSS DRM | Validation | Quality Engineering | Risk Management
- Role
- Process Engineer at Pharmavite
- Location
- Los Angeles, CA, US
- LinkedIn followers
- 500 followers
About Vivek K.
Senior CQV & Equipment Qualification Engineer with 5+ years of experience supporting…
Experience
Process Engineer
Apr 2020 — Present · CA, US
Led cross-functional teams in product complaint analysis, facilitating technical summaries for an rework product. Ensured strict cGMP compliance through equipment and product validation, achieving FDA and cGMP standards. Spearheaded the redesign of Bosch 2PC drug compressing, resulting in a 25% efficiency improvement and a annual cost reduction. Authored in-depth product deviation reports using Lean methodologies, reducing deviations by 30%. Guided drug development for 6 diabetes drugs, contributing to DFSS metrics dashboards. Developed a capital expenditure plan for packaging equipment upgrades, projecting annual cost savings of Designed SOPs, transferred technical knowledge, and coached teams in DRM methodologies. Utilized statistical analysis, DOE, and gage R&R studies for Cleaning Validation, optimizing batch record accuracy.
Education
California State University, Northridge
Master's degree
University of Mumbai
Bachelor of Engineering - BE
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